NCT05232656

Brief Summary

The goal of this study is to expand the use of previously developed patient safety dashboards and patient-centered discharge checklists to three general medicine units in an affiliated community hospital. The safety dashboard and interactive pre-discharge checklist are cognitive aids for clinicians and patients, respectively, that serve to facilitate early detection of patients at risk for preventable harm, including suboptimal discharge preparation. The aims of this study are to:

  1. 1.Enhance the safety dashboard and interactive pre-discharge checklist to include "smart" notifications for hospital-based clinicians when patients are at high risk for adverse events or have identified specific concerns related to discharge based on their checklist responses.
  2. 2.Expand intervention to general medical units at our community hospital-affiliate, BWFH.
  3. 3.Evaluate impact on post-discharge AEs for patients discharged from BWFH who are at risk for preventable harm and hospital readmission.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

1.6 years

First QC Date

January 31, 2022

Last Update Submit

January 31, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Potential Post-Discharge Adverse Events

    Potential post-discharge adverse events will be measured as the number of new or worsening symptoms or signs per patient

    24 months

Secondary Outcomes (2)

  • Actual Post-Discharge Adverse Events

    24 months

  • Preventable Post-Discharge Adverse Events

    24 months

Study Arms (2)

Pre-intervention

NO INTERVENTION

Usual care on three general medicine units. Patients/caregivers do no have access to the discharge preparation checklist. Providers do not have access to the safety dashboard.

Post-intervention

EXPERIMENTAL

Patients/caregivers have access to the pre-discharge preparation checklist. Providers have access to patient safety dashboard.

Behavioral: Pre-Discharge Checklist and Patient Safety Dashboard

Interventions

Pre-discharge preparation checklist for patients to assess discharge readiness. Patient safety dashboard for clinicians to proactively identify at-risk patients.

Post-intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, \>18 years of age, English-speaking
  • Caregivers \>18 years of age designated by patient or patient's healthcare proxy
  • Two or more patient safety risk factors

You may not qualify if:

  • \- Non-English speaking patients for whom we cannot identify an English-speaking healthcare proxy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Vasudevan A, Plombon S, Piniella N, Garber A, Malik M, O'Fallon E, Goyal A, Gershanik E, Kumar V, Fiskio J, Yoon C, Lipsitz SR, Schnipper JL, Dalal AK. Effect of digital tools to promote hospital quality and safety on adverse events after discharge. J Am Med Inform Assoc. 2024 Oct 1;31(10):2304-2314. doi: 10.1093/jamia/ocae176.

Study Officials

  • Anuj K Dalal, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Physician

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 10, 2022

Study Start

September 1, 2018

Primary Completion

March 20, 2020

Study Completion

September 30, 2020

Last Updated

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations